NCT00323856

Safety Study of Alphanate in Previously Treated Patients With Severe Hemophilia A

Phase IV A Study of Immunologic Safety for Alphanate in Previously Treated Patients Diagnosed With Severe Hemophilia A

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Grifols Biologicals, LLC · Industry
• Sex: Male
• Age: 6 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the immunologic and overall safety associated with long-term use of Alphanate in subjects diagnosed with severe hemophilia A (Factor VIII:C less than 0.01 IU/ml), who have been previously treated with plasma-derived Factor VIII products other than Alphanate and who have no history of developing either antibody inhibitors to Factor VIII or nonspecific inhibitors of coagulation.

Detailed description

This is a Phase IV, non-randomized, multicenter study of at least 50 evaluable subjects diagnosed with severe hemophilia A. Enrolled subjects will be treated at home and with in-clinic therapy exclusively with Alphanate as their sole source of Factor VIII concentrate for prophylaxis and treatment of all bleeding episodes and surgical procedures. Subjects will be treated for at least 2 years and a minimum of 50 exposure days, or if 50 exposure days are not reached, for a maximum of 30 months and in accordance with the subject's usual pre-study treatment regimen. Subjects will continue treatment as above or until they develop inhibitors to Factor VIII at a titer greater than or equal to 5 Bethesda units (BU/ml); Factor VIII becomes ineffective at providing hemostasis, or the subject exhibits severe or serious adverse events that prevent completion of the study.

Conditions

• Severe Hemophilia A

Interventions

Type	Name	Description
DRUG	Alphanate SD/HT	Plasma-derived preparation of Factor VIII

Timeline

• Start date: 2003-04-08
• Primary completion: 2018-12-11
• Completion: 2018-12-14
• First posted: 2006-05-10
• Last updated: 2025-01-16
• Results posted: 2022-06-09

Locations

2 sites across 1 country: Poland

Regulatory

• FDA-regulated drug study